At a glance
ClinicalIndex Comparison RecordN/ACompleted· 173 enrolled
Drug / intervention
ATS 3f Enable Aortic Bioprosthesis Model 6000device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
In Brief
A clinical study evaluating ATS 3f Enable Aortic Bioprosthesis Model 6000 for Heart Valve Diseases. Completed, enrolled 173 participants across 10 sites in 5 countries.
Detailed Summary
This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Valve Diseases
CountriesAustria, Germany, Poland, Switzerland, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedMay 2010
Primary CompletionDec 2010
Study CompletionAug 2012
TodayJul 2026
First PostedMay 4, 2010
Enrollment StartMay 1, 2006
Primary CompletionDec 1, 2010
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 16.2 years ago
Interventions
ATS 3f Enable Aortic Bioprosthesis Model 6000device
Replacement Aortic Heart Valve